(27 days)
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.
The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink Implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.
The SurGenTec TiLink-P SI Joint System may be provided sterile single-use or non-sterile.
This document describes an FDA 510(k) clearance for a medical device, the "TiLink-P SI Joint Fusion System." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves performance testing to show the new device meets the same safety and effectiveness standards as the predicate.
However, the provided text does not contain any information about an AI/ML-based device or a study involving AI assistance for human readers. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the mechanical, material, and biological properties of the physical implant device (TiLink-P SI Joint Fusion System), not the performance of an AI algorithm or its impact on human readers.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI device. The text focuses on:
- Device Name: TiLink-P SI Joint Fusion System
- Intended Use: Sacroiliac joint fusion
- Materials: Titanium alloy
- Performance Testing:
- Dynamic vertical shear testing (ASTM F3574)
- Foam block pullout testing (ASTM F543)
- Biocompatibility (ISO 10993)
- Sterilization Validation
The closest thing to "acceptance criteria" in this context is that the device "met the pre-determined acceptance criteria for the verification activities" for these specific mechanical, biological, and sterilization tests. The "study" mentioned is the "Performance Testing" which consists of these engineering and and biocompatibility evaluations.
There is no information in the provided document about:
- A table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.)
- Sample sizes for AI test sets
- Data provenance for AI data
- Number of experts for AI ground truth
- Adjudication methods for AI ground truth
- MRMC comparative effectiveness study
- Standalone AI performance
- Type of ground truth for AI (expert consensus, pathology, etc.)
- Sample size for AI training set
- How AI training set ground truth was established
In summary, the provided document is for a physical medical implant device, not an AI/ML diagnostic or assistive tool. Thus, the specific criteria and study details requested for an AI device are not applicable to the information given.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.